Helicobacter InfectionNCT01723059
Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection
A study testing Standard Triple Therapy and Sequential Therapy in people with Helicobacter Infection, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Infection
- What is being tested?
- Standard Triple Therapy and Sequential Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has signed informed consent Subject is an adult older than 18 yrs old and requires an upper endoscopic evaluation If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.
- Patient has not received prior treatment for H pylori Subject is able to understand and comply with study procedures
Who cannot join
- Recent use (within 4 weeks) of any of the medications used in the treatment of H pylori(Amoxicillin, Clarithromycin, Metronidazole) Subject undergoing endoscopy for acute gastrointestinal bleeding Subject has an allergy to any of the medications used in the treatment of H pylori Subject has a history of esophageal or gastric carcinoma including lymphoma Subject has esophageal varices or undergoing endoscopy for esophageal banding Subject is taking warfarin or clopidogrel Subject has coagulopathy that precludes safe biopsy of the biopsy areas Subject has comorbidity that precludes safe participation in the study Subject is a pregnant female Subject has a history of H. pylori infection. Patient is already enrolled in GI Study. History of UGI surgery other than Nissen Fundoplication
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dallas VAMC
Dallas, Texas, 75216
Byron Cryer, MD, byron.cryer@utsouthwestern.edu
About this study
Official title: Conventional Therapy vs Sequential Therapy for the Treatment of Helicobacter Pylori Infection
Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.
- Conditions
- Helicobacter Infection
- Being tested
- Standard Triple Therapy, Sequential Therapy
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Triple TherapyDrug
Also called Amoxicillin 1000 mg orally twice daily, Omeprazole 20 mg orally twice daily, Clarithromycin 500 mg orally twice daily
for 10 days
Sequential TherapyDrug
Also called Amoxicillin 1000 mg orally twice daily for 5 days, Omeprazole 20 mg orally twice daily for 5 days, Then, Clarithromycin 500 mg orally twice daily for 5 days
total 10 days
| Study group | Role | What they receive |
|---|---|---|
| Standard triple therapy | Other | Gold standard for management of H pylori is amoxicillin 1 gm twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 10 days. Receives: Drug: Standard Triple Therapy |
| Sequential Therapy | Active comparator | Amoxicillin 1 gm twice daily and omeprazole 20 mg twice daily for 5 days followed by metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 5 days. Receives: Drug: Sequential Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication
Measured: 4 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Byron Cryer, Dallas VA Medical Center
- Investigators
- Byron Cryer, MD, Principal investigator, Gastroenterologist, MD VARobert Genta, MD, Study chair, Pathologist, MDElizabeth Coss, MD, Study chair, Gastroenterology Fellow, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723059
- Sponsor's protocol ID
- 11-060
- Status last verified
- Nov 2012
- First submitted
- 5 Nov 2012
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Therapy vs Sequential Therapy for the Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT01723059
- Acronym / sponsor ID
- 11-060
- Conditions
- Helicobacter Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard triple therapy | Other | Drug: Standard Triple TherapyGold standard for management of H pylori is amoxicillin 1 gm twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 10 days. |
| Sequential Therapy | Active comparator | Drug: Sequential TherapyAmoxicillin 1 gm twice daily and omeprazole 20 mg twice daily for 5 days followed by metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 5 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has signed informed consent Subject is an adult older than 18 yrs old and requires an upper endoscopic evaluation If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.
- Patient has not received prior treatment for H pylori Subject is able to understand and comply with study procedures
Key exclusion criteria (1 listed)
- Recent use (within 4 weeks) of any of the medications used in the treatment of H pylori(Amoxicillin, Clarithromycin, Metronidazole) Subject undergoing endoscopy for acute gastrointestinal bleeding Subject has an allergy to any of the medications used in the treatment of H pylori Subject has a history of esophageal or gastric carcinoma including lymphoma Subject has esophageal varices or undergoing endoscopy for esophageal banding Subject is taking warfarin or clopidogrel Subject has coagulopathy that precludes safe biopsy of the biopsy areas Subject has comorbidity that precludes safe participation in the study Subject is a pregnant female Subject has a history of H. pylori infection. Patient is already enrolled in GI Study. History of UGI surgery other than Nissen Fundoplication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Triple TherapyAlso: Amoxicillin 1000 mg orally twice daily, Omeprazole 20 mg orally twice daily, Clarithromycin 500 mg orally twice dailyfor 10 days | Drug | Standard triple therapy |
| Sequential TherapyAlso: Amoxicillin 1000 mg orally twice daily for 5 days, Omeprazole 20 mg orally twice daily for 5 days, Then, Clarithromycin 500 mg orally twice daily for 5 daystotal 10 days | Drug | Sequential Therapy |
Primary outcome
Helicobacter pylori eradication
Time frame: 4 weeks after completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byron Cryer, MD principal investigator
Gastroenterologist, MD VA
Robert Genta, MD study chair
Pathologist, MD
Elizabeth Coss, MD study chair
Gastroenterology Fellow, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Triple Therapy and Sequential Therapy in people with Helicobacter Infection, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byron Cryer, MD (214-857-1603, byron.cryer@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication (time frame: 4 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.